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To evaluate the efficacy and safety of adjuvant CDK4/6 inhibitors in patients with hormone receptor-positive/human epidermal growth factor receptor 2-negative breast cancer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Adjuvant CDK4/6 inhibitor | CDK4/6 inhibitors are drugs that block cell division in cancer cells. They are used with hormonal therapy for hormone receptor-positive breast cancer and may improve survival. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CDK4/6 inhibitor | Drug | abemaciclib OR ribociclib |
|
| Measure | Description | Time Frame |
|---|---|---|
| Invasive Disease-free Survival (iDFS) | Invasive disease-free survival time is defined as the time from date of randomization until the first invasive disease recurrence of the following events: invasive ipsilateral breast tumor recurrence, invasive contralateral breast cancer, local/regional invasive recurrence, distant recurrence and death from any cause. | From the date of surgery until time of event up to 2 years. |
| Measure | Description | Time Frame |
|---|---|---|
| Disease-free Survival (DFS) | Disease-free survival time is defined as the time from date of surgery until the first disease recurrence of the following events: invasive ipsilateral breast tumor recurrence, invasive contralateral breast cancer, local/regional invasive recurrence, non-breast primary invasive cancer, ductal carcinoma in situ (DCIS),or distant recurrence and death from any cause. | From the date of surgery until time of event up to 2 years |
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Inclusion Criteria:
Exclusion Criteria:
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Breast cancer patients meeting current guideline recommendations and planning to receive adjuvant CDK4/6 inhibitors
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Wenjin Yin, M.D. | Contact | 86(21)68385569 | yinwenjin@renji.com |
| Name | Affiliation | Role |
|---|---|---|
| Wenjin Yin, M.D. | Renji Hospital,School of Medicine, Shanghai Jiaotong University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Renji Hospital, School of Medicine, Shanghai Jiaotong University | Recruiting | Shanghai | 200127 | China |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| Overall Survival (OS) | Overall survival is defined as the time from surgery to death from any cause. | From the date of surgery until time of event up to 2 years |
| Adverse events | Adverse events will be assessed according to the NCI CTCAE v5.0. | From the date of starting CDK4/6 inhibitor to the end of the treatment (up to approximately 3 years) |
| D017437 |
| Skin and Connective Tissue Diseases |